Title: Coordinator II, DMC/EAC
Full-Time
RemoteLocations
Remote –U.S.A
United States of America, 000000, USA
Job Category: DMC/EAC
Job Description:
Company Information
At Advarra, we are passionate about making a difference in the world of clinical research and advancing human health. With a rich history rooted in ethical review services combined with innovative technology solutions and deep industry expertise, we are at the forefront of industry change. A market leader and pioneer, Advarra breaks the silos that impede clinical research, aligning patients, sites, sponsors, and CROs in a connected ecosystem to accelerate trials.
Company Culture
Our employees are the heart of Advarra. They are the key to our success and the driving force behind our mission and vision. Our values (Patient-Centric, Ethical, Quality Focused, Collaborative) guide our actions and decisions. Knowing the impact of our work on trial participants and patients, we act with urgency and purpose to advance clinical research so that people can live happier, healthier lives.
At Advarra, we seek to foster an inclusive and collaborative environment where everyone is treated with respect and diverse perspectives are embraced. Treating one another, our clients, and clinical trial participants with empathy and care are key tenets of our culture at Advarra;we are committed to creating a workplace where each employee is not only valued but empowered to thrive and make a meaningful impact.
Job Overview Summary
Advarra is a clinical research compliance company. Biostatistical Services focuses on oversight of research through Data Monitoring Committees (DMC) and Endpoint Adjudication Committees (EAC). The DMC/EAC Coordinator II provides administrative, and operations support to the overall operations of DMC and EACs. Support is provided by administering DMC/EAC member engagement, onboarding, meeting management, minutes, preparation of materials, result letters, and all other aspects of administering the DMC / EAC committee process. This position will also offer general administrative support and back-up coverage for other operations staff.
Job Duties &Responsibilities
- Works directly with DMC/EAC Committee Members to organize meetings, collect and post data packets for Committee Members review meeting preparation.
- Communicates as directed with Sponsor Company project manager and safety teams to ensure all information is being provided to the DMC/EAC in a timely manner (i.e., SAEs, enrollment, etc.). Creates study update reports with information received and submits to Committee Members.
- Creates meeting reports for signature by Board Members via transcription.
- Creates notes to charter and memos as necessary to record action within the Committee and with the Sponsor.
- Maintains communication tracking sheets and flow sheets to aid in Committee management.
- Maintains secure extranet accounts.
- Meeting planning –web/teleconferences, in-person same day, in-person overnight.
- Data management –organize and post data packets to the Extranet and archive all data in computer files by study.
- Manages stipend and expense requests, creates payment reports and submits them for payment.
- Archives final documents for study close-out.
- Presents documents for signatures, collects signature pages and integrates into final reports.
- Fills any special requests of the DMC/EAC and Sponsor Project Manager within scope and alerts management when requests are outside of scope.
- Provide administrative support for DMC / EAC meetings.
- Facilitate written and oral communications with members and consultants for expert and consultation reviews.
- Plan, Schedule and manage video-conference meetings.
- Ensure meeting attendees are equipped with the information, tools, and documents necessary to effectively participate in assigned meetings.
- Record and transcribe meeting minutes, ensuring components as required by the appropriate regulatory body and Advarra operating procedures are accurately identified and documented.
- Assist in Department and Company projects as they relate to Biostatistical Services.
- Provide coverage within the team and other teams as needed
- Quality control of digital images received from Sponsor via Sponsors platform
- Work within the electronic adjudication systems to gather data and create documents
- Other duties as assigned
Location
This role is open to candidates working remotely in the United States
Basic Qualifications
- Bachelor’s degree or associate degree with 2+ years industry or office administration experience
- 1+ years specific experience in regulatory committee administration
- Extremely detail-oriented and possess problem solving skills
- Ability to communicate effectively verbally and in writing, in English with attention to detail
- Excellent interpersonal skills to work effectively with others and provide high levels of customer service
- Ability to follow instructions and work independently as required;plan, organize, schedule and complete work within competing deadlines and priorities
- Ability to adapt to changes in office technology, equipment, and/or processes
- Demonstrated consistency and dependability in attendance, quantity, and quality of work
- Must be able to multi-task and switch to-and-from projects easily and with attention to detail
Preferred Qualifications
- 2+ years of DMC, EAC or Clinical Research Industry experience
- Exhibit an advanced knowledge and understanding of regulatory requirements and applications
Physical and Mental Requirements
- Sit or stand for extended periods of time at stationary workstation
- Regularly carry, raise, and lower objects of up to 10 Lbs.
- Learn and comprehend basic instructions
- Focus and attention to tasks and responsibilities
- Verbal communication;listening and understanding, responding, and speaking in English
- Specific vision abilities required by the job include color vision, close vision, distance vision, depth perception, and the ability to adjust focus in order to process medical images and other DMC/EAC materials
- This position requires regular oral/written interaction with clients, team members and management in English
Advarra is an equal opportunity employer that is committed to diversity, equity and inclusion and providing a workplace that is free from discrimination and harassment of any kind based on race, color, religion, creed, sex (including pregnancy, childbirth, and related medical conditions, sexual orientation, and gender identity), national origin, age, disability or genetic information or any other status or characteristic protected by federal, state, or local law. Advarra provides equal employment opportunity to all individuals regardless of these protected characteristics. Further, Advarra takes affirmative action to ensure that applicants and employees are treated without regard to any of these protected characteristics in all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and separation from employment.
Pay Transparency Statement
The base salary range for this role is $36,200 –$61,500. Note that salary may vary based on location, skills, and experience and may vary from the amounts listed above. This position may also be eligible for a variable bonus in addition to base salary as well as health coverage, paid holidays, and other benefits.